Website:
bioksha.in
Job details:
USV (Pharma) is Hiring Senior Manager - QA (Sterile) for USFDA Formulation Manufacturing Plant based at Daman near Vapi.
We are looking for dynamic professionals having more than 15 years of experience in hard core injectables (Liquid Vials, Ophthalmic and Pre-filled syringes).
The incumbent must be having the thorough knowledge of IPQA, Qualification and Validation, QMS Aseptic techniques and practices.
Should have faced the Regulatory Audit (USFDA, MHRA, EU GMP, TGA) and should be able to explain the auditors during inspections.
Excellent verbal and written communication are expected.
- Oversee and manage QMS processes including Deviation Management, CAPA, Change Control, Risk Management, and Product Quality Reviews (PQRs).
- Lead Quality investigations and root cause analysis for process deviations and quality events.
- Ensure timely closure of audit observations and effective CAPA implementation.
- Monitor and review QMS KPIs and drive continuous improvement initiatives.
- Coordinate and lead internal and external audits (regulatory and customer).
- Ensure sterile area compliance through regular review of processes, documentation, and trending of quality data.
- Lead training initiatives related to QMS and GMP for the QA and production teams.
- Collaborate with cross-functional teams (Production, QC, Regulatory Affairs, etc.) to ensure QMS effectiveness and product quality.
- Review and approve master documents related to QMS (SOPs, protocols, reports).
- Support data integrity initiatives and ensure compliance with ALCOA+ principles.
- Maintain readiness for regulatory inspections and support inspection management activities.
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